One adverse outcome of cleft lip and palate repair is the presence of an oronasal fistula. Many authors have written on this subject but focus on whether cleft palate repair techniques reduce the rate of formation.1–3 One aspect of cleft repair that deserves more attention is the anterior nasal floor of the primary palate at the point of the alveolus, between the anatomical locations of the cleft lip and palate repairs. Some surgeons address this area at the time of cleft lip repair; others address it at the time of cleft palate repair; and some do not address this portion of the cleft until the time of alveolar bone grafting. This study focuses on the fistula rate at the alveolus when the anterior nasal floor is repaired at the time of cleft lip repair.
If the anterior nasal floor is left unrepaired at the time of cleft lip repair, closure must be performed during either the palate repair or alveolar bone graft procedure. Some surgeons prefer this approach because of concerns that local flaps may distort the tissues in the region, thereby complicating subsequent operations.4 However, visualization and suturing in this area is more difficult during a palate repair. In addition, the nasal floor lining of the primary palate may not completely cover the anterior palate and alveolus in wide clefts. In these cases, oronasal closure relies on the palatal mucoperiosteal flaps, which can be challenging in that region. When repair of the alveolar region is deferred until the time of alveolar bone grafting, the patient must live with a symptomatic fistula until they are old enough for the bone graft. These patients thus live the first decade of their lives with nasal regurgitation of food and liquids until definitive repair at the time of bone graft. This has a negative impact on a child’s quality of life and further contributes to the stigma of a cleft.
The traditional approach to closing the anterior nasal floor of the primary palate is with Millard medial and lateral flaps.5–7 These flaps are created from the medial and lateral lip elements along the cleft margin. The exact technique used to implement these flaps varies between authors, but the general principle is constant.5–7 The flaps are rotated into the cleft to close part of the anterior nasal floor at the time of cleft lip repair. However, these flaps are nonanatomical, thin, and cover only a small area. Other techniques have been developed using similar flaps based at the anterior region of the nasal cavity.8,9
Another option is to perform either a one- or two-layer closure of the anterior nasal floor using medial and lateral nasal wall lining flaps. The one-layer closure involves using a medial flap of mucoperiosteum and mucoperichondrium from the vomer and septum and a lateral flap of mucoperiosteum from the piriform aperture.10–14 These are brought together and sutured at the center of the cleft through the alveolus. The undersurface (oral side) of this one-layer repair heals in secondarily and mucosalizes. The two-layer closure involves basing the medial flap inferiorly and the lateral flap superiorly.15 The flaps are brought across the cleft, and the lateral flap lines the nasal cavity and the medial flap lines the oral cavity. This is similar to the vomer flap, where the movement comes entirely from the medial nasal lining, which is brought across the cleft and sutured to the lateral aspect of the cleft.16,17
At our institution, either medial and lateral flaps or one-layer anatomical nasal lining flaps have been used for nasal floor closure at the time of the primary cleft lip repair. With both techniques, cleft palate repair and alveolar bone grafting are performed at the standard ages. A retrospective review was performed to assess the efficacy of nasal lining flaps compared with medial and lateral flaps for reducing the presence of alveolar fistulas after cleft palate repair in patients with complete unilateral and bilateral cleft lip and palate.
PATIENTS AND METHODS
Medial and Lateral Flap Elevation and Closure
Millard-type medial and lateral oral mucosa flaps are based on the medial and lateral lip elements at the site of the cleft. The medial flap is marked along the medial lip element starting distally at the perpendicular cut across the vermillion border and extending along the cleft margin toward the cleft sulcus at the oral and nasal mucosa fusion line. The lateral flap is marked along the lateral lip element cleft margin starting distally at the perpendicular cut across the vermilion border with its base at the cleft sulcus.
Medial and lateral flaps are raised during lip dissection. Once dissection is complete, they are trimmed to the desired length, rotated transversely, and sutured into place to reconstruct the oral side of the anterior nasal floor and the gingival-buccal sulcus across the cleft. If additional tissue is required to close the region, a lateral nasal wall mucosal flap is elevated off the aperture and turbinate. This is brought medially and sutured into the tip and distal edge of the medial flap. The nasal lining is not closed beyond the floor of the vestibule. Therefore, complete closure of the nasal floor relies on the anterior closure of the later palate repair. Complete nasal floor closure is not always possible when there is a particularly wide cleft palate. In those instances, the floor at the level of the alveolus is left open until the alveolar bone graft operation.
Anatomical Nasal Lining Flaps: Elevation and Closure
The nasal lining flaps are created from the mucosal lining off the vomer and septum medially and the mucosal lining off the maxilla laterally. The flaps are incised and elevated after creating the lip incisions. They can be used with any type of lip repair.
The lateral flap is elevated in the anterior to posterior direction, starting from the base of the lateral flap at the gingivobuccal sulcus along the cleft margin (Figs. 1 and 2). The lateral flap is transected at its base, as it is not required for the nasal floor repair (Figs. 1 and 2). The lateral flap was originally used for inset into the lateral vestibular lining to allow for further advancement of the alar base. However, this often led to the development of a significant scar band in this region and minimal additional advancement. Therefore, the lateral flap was later transected without notable drawback. The lateral nasal lining flap is elevated in the subperiosteal plane along the hard palate cleft margin as far posteriorly as possible (typically up to 1 cm) and up the piriform rim to the nasal bones. This results in a wide-based, thick sheet of mucosal lining that advances easily across the cleft. Elevation of the lateral nasal lining flap releases all the tethering forces on the mucosa and the alar base away from the piriform rim.
The medial nasal lining flap is elevated similarly, starting at the base of the medial flap in unilateral clefts and on the premaxilla in bilateral clefts (Figs. 1 and 2). The incision is extended posteriorly along the gingivomucosal border onto the vomer (Fig. 3). In the bilateral cleft, a narrow mucosal bridge is preserved in the midline of the premaxillary segment to maintain perfusion and venous outflow from the premaxillary segment (Fig. 2, right). The medial nasal lining flap is elevated in the subperiosteal plane extending as far posteriorly as possible (typically up to 1 cm). This flap requires elevation superiorly in the subperichondrial plane on the septum (Fig. 3).
Most of the advancement across the cleft comes from the lateral nasal lining flap, which is sutured to the medial lining flap as a single-layer closure. The closure extends as far posteriorly as possible through the alveolus and usually reaches a point near the incisive foramen (Figs. 4 and 5). In our experience, these nasal lining flaps will reach one another for primary closure despite the width of the cleft. This is a single-layer closure of the nasal floor, and the oral side is left to heal secondarily and mucosalize (Fig. 6).
Institutional review board approval was obtained to retrospectively evaluate cases performed by two cleft and craniofacial surgeons at Lucile Packard Children’s Hospital at Stanford University between 2006 and 2014. Patients with complete unilateral or bilateral cleft lip and palate with follow-up of at least 6 months after cleft palate repair were included. A separate cohort included patients with a complete cleft lip involving the primary palate including all or part of the alveolus. Patients were excluded if they did not have at least 6 months of follow-up after cleft lip repair. The type of nasal floor closure (i.e., anatomical nasal lining flaps or medial and lateral flaps) was recorded for each patient. The primary outcome was the presence of a symptomatic and/or visible oronasal fistula after cleft palate repair. The presence of a fistula was determined based on patient history and physical examination. The location of the fistula was recorded if visible. All oronasal fistulas were categorized based on whether the fistula involved the alveolus, the incisive foramen, the hard palate, the junction of the hard and soft palate, or the soft palate. Fistulas involving both the alveolus and the incisive foramen were classified as being alveolar fistulas. Patients with symptoms of nasal regurgitation and no visible fistula were assumed to have a microfistula and recorded as positive for a fistula.
Data analyses were performed using either a t test (Microsoft Excel; Microsoft Corp., Redmond, Wash.) or Fisher’s exact test (GraphPad Software, Inc., San Diego, Calif.). Odds ratios were calculated using MedCalc (MedCalc, Ostend, Belgium). A value of p < 0.05 was considered statistically significant.
Sixty-four patients were included in the study. Thirty-seven underwent closure with nasal lining flaps performed by one surgeon, and 27 underwent closure using medial and lateral flaps performed by a second surgeon. Patients were identified starting at the beginning of both surgeons’ practices at Stanford University and Lucile Packard Children’s Hospital.
The average age at the time of cleft lip repair was 4.97 months in both groups (p = 0.99, t test). The average age at the time of cleft palate repair was 12.9 months for the group with nasal lining flaps and 11.8 months for the patients with medial and lateral flaps. The ratio of male to female patients was 26:11 in the group with nasal lining flaps and 19:8 in the group with medial and lateral flaps (p = 1.00, Fisher’s exact test). The ratio of unilateral to bilateral clefts was 26:11 in the group with nasal lining flaps and 19:8 in the group with medial and lateral flaps (p = 1.00, Fisher’s exact test). Average follow-up time after cleft palate repair was 1.48 years in the patients with nasal lining flaps and 6.08 years in the patients with medial and lateral flaps (p < 0.001, t test). These data are shown in Table 1.
There was a statistically significant difference in the fistula rates at the alveolus between the two groups, with 3 percent (one of 37) in the patients with nasal lining flaps and 30 percent (eight of 27) in the patients with medial and lateral flaps (p = 0.0032 with Fisher’s exact test; OR, 0.066; 95 percent CI, 0.008 to 0.567). The one patient in the nasal lining flap cohort who developed an alveolar fistula had a notably wide bilateral cleft lip and palate. The alveolar fistulas seen in patients with medial and lateral flaps were not necessarily attributable to surgical dehiscence but, in some cases, were attributable to the inability to close the alveolus following both lip and palate repair. The rates of surgical dehiscence and resultant fistula formation posterior to the incisive foramen were similar in both groups (5.4 percent and 3.7 percent; p = 1.00, Fisher’s exact test). There was no difference in the rate of fistulas at any of the other locations in the palate. These results are shown in Tables 2 and 3.
The overall fistula rate was higher in patients with bilateral clefts, but this was not statistically significant. In patients with nasal lining flaps, 12 percent with a unilateral cleft developed a fistula at any location (three of 26), compared to 36 percent with a bilateral cleft (four of 11). In patients with medial and lateral flaps, 42 percent of those with a unilateral cleft developed a fistula (eight of 19), compared to 50 percent with a bilateral cleft (four of eight). These results are shown in Tables 2 and 3.
The subgroup of patients with a complete cleft lip and a cleft of the alveolus without extension into the secondary palate was evaluated separately and included nine patients (Table 4). There were five who underwent closure with nasal lining flaps and four with medial and lateral flaps. The average age at the time of cleft lip repair was 3.89 months for the patients with nasal lining flaps and 4.50 months for the patients with medial and lateral flaps (p = 0.49, t test). Cleft palate repairs were not required in this subset, as the clefts did not involve the secondary palate. All patients in this subset had a unilateral cleft lip and alveolus (p = 1.00, Fisher’s exact test). Average follow-up since cleft lip repair was 3.70 years and 7.76 years (p = 0.017, t test) in those undergoing repair with nasal lining flaps and medial and lateral flaps, respectively. These results are shown in Table 4.
All five patients in the subset with nasal lining flaps achieved complete closure of the nasal floor, with a fistula rate of 0. In contrast, three of the four patients in the subset with medial and lateral flaps were found to have a fistula because of the cleft being larger than what the medial and lateral flaps could close (p = 0.0476, Fisher’s exact test; OR, 0.039; 95 percent CI, 0.001 to 1.252). These results are shown in Table 4. These three patients’ fistulas were closed at the time of alveolar bone grafting.
Palatal fistulas are a negative outcome in cleft repair that can result in distortion of speech and regurgitation of liquid and food through the nose. Problems with speech and nasal discharge can have a significant negative impact on quality of life and psychosocial development.
Many surgeons have evaluated cleft palate repair techniques in an effort to reduce fistulas in the secondary palate. However, few have looked specifically at the junction between the lip and palate repairs, which frequently results in alveolar fistulas. Many surgeons do not consider this finding a fistula per se, either because they do not attempt soft-tissue closure of the nasal floor in this location or because the traditional techniques are unreliable, with high rates of failure. Nevertheless, these patients live with a fistula for years before it can be repaired.
The optimal technique for nasal floor closure at the alveolus consists of drastically different approaches and is not a subject frequently discussed. Our study sought to evaluate how well the anatomical nasal lining flaps achieved successful closure of this region in comparison with the traditional medial and lateral flaps. We found a statistically significant reduction in alveolar fistulas with the nasal lining flaps in both unilateral and bilateral complete cleft lip and palate deformities when compared to medial and lateral flaps (3 percent versus 30 percent; p = 0.003, Fisher’s exact test). Our findings are similar to those seen by Mendoza and Pérez, who showed that only 8 percent (18 of 365) of patients with a similar type of nasal lining flap closure developed alveolar fistulas.10
In our cohort of 37 patients with nasal lining flaps, we found that most fistulas occurred at the incisive foramen (11 percent). All four of these cases had a bilateral cleft lip and palate. This indicates an inherent weak point in this area with this technique in the bilateral deformity. The weakness occurs where the anterior nasal floor closure from the lip repair meets the posterior nasal floor closure from the palate repair. Tension during bilateral repairs is highest in this location. In addition, this area corresponds with the distalmost ends of the mucoperiosteal flaps used for closure of the oral side during the formal palate repair. Given these results, modifications are being considered to reduce fistula formation at this location in the bilateral cleft lip and palate.
The nasal lining flaps are thick and robust. We have found they can be used successfully on clefts of any width. Nasoalveolar molding may narrow the distance of alveolus but is not necessary for implementation of these nasal lining flaps. These flaps are independent of the skin markings and may therefore be used with any skin repair technique. They are easy to dissect, and they anatomically reconstruct the nasal floor of the primary palate. We find that it is easiest to repair the nasal floor of the primary palate at the time of the primary lip repair, as it is simpler to approach this area anteriorly when the lip is open. It should not be confused with a gingivoperiosteoplasty and does not prevent the need for alveolar bone graft. However, their use makes the eventual bone graft procedure easier, as the nasal floor is already closed. In contrast, primary nasal floor closure during the alveolar bone graft procedure can be tenuous with thin flaps and may result in poor graft take.
We found that the nasal lining flaps were especially beneficial for a unilateral cleft lip and alveolus that extends only to the incisive foramen. In this scenario, the flaps easily cover the alveolar gap with minimal additional dissection. There was a lower percentage of patients with alveolar fistulas in the nasal lining flap group compared with the medial and lateral flap group (0 percent versus 75 percent; p = 0.048, Fisher’s exact test).
The primary limitation of this study is that patients were treated by two separate surgeons, one using nasal lining flaps and the other using medial and lateral flaps. Ideally, one surgeon would perform each of these techniques in a randomized, prospective fashion. Measures were taken to minimize this potential confounding variable in the data collection and analysis phases by including cases from the start of each surgeon’s practice and by having all charts reviewed by the same individual.
Another limitation is that the width of the clefts are not quantified and therefore outcomes for wide versus narrow clefts are not assessed. Furthermore, the effects on premaxillary and alveolar bone growth because of scarring at the nasal lining flap donor sites were not evaluated. There may be potential deleterious effects on maxillary growth; however, this is unknown and not evaluated in this study at this young age. Other factors that were not assessed include the effects on dental occlusion, and orthodontic treatment (timing and length). Further long-term analysis is warranted.
The anatomical nasal lining flaps have many advantages in primary cleft lip and palate repair for both the unilateral and bilateral complete cleft lip and palate. This technique forms an anatomical closure of the nasal floor at the time of primary lip repair, when visualization of that region is easiest. The repair is simple to perform, has a high success rate, and at our institution has been shown to have a lower alveolar fistula rate after cleft lip and palate repairs when compared to medial and lateral flap closure. Closure of the alveolar region with soft tissue during infancy improves the quality of life for patients by eliminating nasal regurgitation of fluid and food. It also makes the eventual bone graft easier, as the nasal floor is already closed. Therefore, we advocate for closing the anterior nasal floor at the time of cleft lip repair with anatomical nasal lining flaps.
The authors thank Chris Gralapp for creating the illustrations in this article.
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